Cleaning validation studies for reprocessable medical devices have historically been designed based on AAMI TIR30:2011/(R)2016 and the 2015 Food and Drug Administration (FDA) reprocessing validation guidance document.

As devices, reprocessing technology, and science evolves, so do industry standards.

The AAMI Sterilization Standards Committee working group has adopted a new method, ultimately replacing TIR30. ANSI/AAMI ST98 provides more detailed device testing requirements and serves as a unified guide for manufacturers for cleaning and reprocessing medical devices before each clinical use.

Here are a few differences between AAMI TIR30 and ANSI/AAMI ST98: